Global Quality Compliance Specialist - Complaints
Grasslands Corporate Office - Englewood, CO
$55,000.00 - $70,000.00 Salary/year
Paragon 28’s growth continues and we’re looking for more great employees! Now is your chance to join this public company dedicated to improving patient’s quality of life with the treatment of the most challenging foot and ankle conditions! We are currently looking to fill the position of Global Quality Compliance Specialist Complaints with a starting range of $55,000 - $70,000/year, dependent upon experience, education, and skills. This role is eligible for remote work within the US. .
The Global Quality Compliance Specialist researches and investigates complaints associated with medical device products and initiates/completes medical device regulatory reporting for adverse events. Provides assistance in all areas of complaint handling including supporting adverse event reporting to ensure the complaint(s) is handled in an accurate and timely fashion. This role ensures completeness and consistency of documentation for these post-market activities under limited supervision.
- Act as the primary resource for intake of global complaints and feedback under limited supervision.
- Assess details of an event against procedural requirements to classify the event as a complaint, feedback and/or service incident; proceed accordingly per procedures.
- Perform follow-up actions to obtain additional event information by effectively collaborating cross-functionally, as applicable, with Sales, Marketing, Quality, Engineering, Clinical, and End Users directly; including information made available through internal data sources such as ERP, Complaint handling databases, etc.
- Evaluate complaint details in a timely manner to determine chain of events and conduct accurate assessments of the event to determine reportability.
- Prepare and submit Medical Device Reports and adverse event reports globally on-time per established requirements and provide professional, timely responses to all Regulatory Authority requests pertaining to complaints and/or medical device reports.
- Conduct timely re-assessments of an event when new information has been received to determine if an initial or supplemental MDR or other applicable adverse event report is required per applicable regulations.
- Proper determination for escalation of events to CAPA or Recall when required per documented procedures.
- Responsible for completing work activities on-time and in accordance with established requirements.
- Effective communication and collaboration with other Quality Compliance associates, as well as all members of the organization.
- Raise awareness of Complaint related procedures within the organization and assist Quality Management in the identification and resolution of quality issues associated with complaints.
- Other duties as assigned.
- Associate Degree or relevant experience required.
- Experience in complaint handling and medical device reporting; Domestic and International.
- Familiarity with 21 CFR 820, ISO13485, working in a regulatory environment as well as reading/interpreting regulatory requirements and standards.
- Strong customer service/interpersonal skills to handle phone calls, emails with external customers, internal customers, and suppliers.
- Basic understanding of corrective and preventive action and medical device recalls.
- Basic computer skills (MS Office suite as well as Adobe Acrobat).
P28 is a leader in the development and distribution of medical solutions for the foot and ankle industry. Established in 2010, every member of our inspired and dedicated team serves a vital role in the achievement of our mission: to strategically build a company around the core principles that drive innovation and quality. We're located at 14445 Grasslands Dr., just off E-470 and Peoria St. on the east side of Englewood, CO.
We offer 100% employer-paid medical, dental and vision benefits for employee only coverage and generously subsidized premiums for coverage with dependents in addition to company paid life and disability benefits. Voluntary life/disability/accident options as well as flexible spending account plans are also available. We have a safe harbor 401(k) Plan with 3% match and an Employee Stock Purchase Plan, which allows purchase of P28 stock at a discounted rate! You are able to accrue 19 days of PTO over 12 months to maintain a fulfilling work/life balance. Our working environment is considered Colorado Casual. Onsite we have a fresh food kiosk, free parking and will have a new, expanded fitness center in January 2023!
Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit and business need.
Notice to Recruiters and Staffing Agencies: to protect the interests of all parties, Paragon 28, Inc. will not accept unsolicited resumes or referrals from any source other than directly from a candidate or an approved vendor that has a written and signed agreement in place through the Paragon 28, Inc. HR department. Please do not contact or forward resumes or referrals to our company employees. Any unsolicited resumes will be considered Paragon 28, Inc. property. Paragon 28, Inc. is not responsible for any charges or fees related to unsolicited resumes or referrals.